EP2925221B1 - Catheter with depth electrode for dual-purpose use - Google Patents
Catheter with depth electrode for dual-purpose use Download PDFInfo
- Publication number
- EP2925221B1 EP2925221B1 EP13858315.8A EP13858315A EP2925221B1 EP 2925221 B1 EP2925221 B1 EP 2925221B1 EP 13858315 A EP13858315 A EP 13858315A EP 2925221 B1 EP2925221 B1 EP 2925221B1
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- EP
- European Patent Office
- Prior art keywords
- catheter assembly
- tube
- lumen
- depth electrode
- principal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000012530 fluid Substances 0.000 claims description 16
- 210000005013 brain tissue Anatomy 0.000 claims description 13
- 210000004556 brain Anatomy 0.000 claims description 12
- 238000003780 insertion Methods 0.000 claims description 12
- 230000037431 insertion Effects 0.000 claims description 12
- 229920002635 polyurethane Polymers 0.000 claims description 8
- 239000004814 polyurethane Substances 0.000 claims description 8
- 238000007917 intracranial administration Methods 0.000 claims description 7
- 238000000034 method Methods 0.000 description 6
- 238000012544 monitoring process Methods 0.000 description 6
- 210000001519 tissue Anatomy 0.000 description 4
- 230000007177 brain activity Effects 0.000 description 3
- 238000012377 drug delivery Methods 0.000 description 3
- 208000016285 Movement disease Diseases 0.000 description 2
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- 238000000429 assembly Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 210000004958 brain cell Anatomy 0.000 description 1
- 208000029028 brain injury Diseases 0.000 description 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
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- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 206010015037 epilepsy Diseases 0.000 description 1
- 230000002397 epileptogenic effect Effects 0.000 description 1
- 238000012966 insertion method Methods 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 230000009972 noncorrosive effect Effects 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical compound [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 1
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- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
- A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
- A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
- A61B5/293—Invasive
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6868—Brain
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0534—Electrodes for deep brain stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
- A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0693—Brain, cerebrum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
- A61N1/36064—Epilepsy
Definitions
- the present invention relates to catheter assemblies for treatment of brain tissue and to devices for electrical stimulating/monitoring of brain activity.
- Depth electrodes have been utilized for a variety of brain-monitoring and brain-stimulating purposes related to epilepsy and a variety of movement disorders.
- monitoring of electrical activity is important in ascertaining the focus of epileptogenic brain tissue and cells for the purpose of determining possibilities for later removal or treatment.
- highly-targeted electrical stimulation using depth electrodes has been used to suppress undesirable behavior resulting from various movement disorders.
- Small brain-insertable catheters have been used for a variety of fluid-removal and drug-delivery purposes. Fluid removal is often necessary or helpful in connection with brain injuries; likewise highly-targeted drug delivery to very specific portions of brain tissue is useful in a variety of medical situations.
- insertion of both catheter devices and depth electrode devices is medically appropriate or helpful, but this of necessity has involved plural insertions into brain tissue. Fluid-movement and electrical functions are often needed or highly desirable at essentially the same locations within the brain tissue. It should be evident that insertions into brain tissue are risky procedures and that minimizing the number of insertions is desirable.
- US 2003/0014016 A1 discloses a method and device for introducing and navigating the device in a spinal subarchnoid space, the device being a catheter or sheath defining a first passageway. Intracranial access may be facilitated by introducing a second device through the first passageway, wherein the intracranial space can be navigated to place EEG electrodes in brain tissue.
- US 2003/0014016 A1 at least does not disclose a depth electrode within a secondary lumen and having spaced electrical contacts along the flexible tube.
- US 2004/0215162 A1 describes an intracranial catheter assembly comprising an outer catheter with a lumen and an inner catheter adapted to be received within said lumen.
- an intracranial catheter assembly is provided for precise treatment of brain tissue.
- the catheter assembly of this invention overcomes certain problems and shortcomings of the prior art and provides a unique structure satisfying plural intracranial monitoring and treatment needs.
- the catheter assembly of this invention includes (a) an outer flexible tube having a proximal end, a principal lumen extending therealong to the proximal end, and at least one radial aperture through the wall communicating with the lumen, wherein the at least one radial aperture and the principal lumen are configured to cooperate for transferring fluids between a tissue region in the patient's brain and an external receptacle or device, the tube further defining a secondary lumen next to and separate from the principal lumen and adjacent to the tube outer-wall surface and extending therealong to the proximal end, and (b) a depth electrode within the secondary lumen, extending along the length thereof and out the proximal end, the depth electrode having spaced electrical contacts exposed along the flexible tube, thereby facilitating concurrent electrical sensing and fluid flow
- the outer tube includes windows therethrough which are aligned with the electrical contacts of the depth electrode and has a plurality of radial apertures axially-spaced along and around the outer tube.
- the outer tube includes windows
- the assembly further includes a rigid stylet received within the principal lumen for purposes of insertion of the catheter assembly into the patient's brain.
- the rigid stylet is withdrawn from the assembly after insertion is complete.
- a luer fitting is inserted into the principal lumen at the proximal end during treatment.
- the luer fitting is a connector for connecting the catheter assembly with a drainage system or other device.
- the electrical contacts along the depth electrode have diameters such that they extend at least partially into the windows, thereby facilitating their electrical contact with brain tissue. In other embodiments, the electrical contacts along the depth electrode are substantially flush with the outer- wall surface.
- the principal and secondary lumens of the catheter assembly are substantially circular, the size of the secondary lumen is smaller than the size of the principal lumen, and the tube outer-wall surface is substantially smooth and has a major portion (cylindrical) substantially parallel to the surface of the principal lumen, a minor portion (cylindrical) substantially parallel to the surface of the secondary lumen, and transitional portions therebetween on either side.
- Such transitional portions are other than concave; it is preferable that in cross-section each transitional portions be substantially linear.
- the largest cross-dimension of the outer flexible tube not exceed about 5.0 millimeters and be not smaller than about 1.0 millimeter. It should be noted, however, that many different cross-dimension sizes are acceptable for the catheter assembly and these will be apparent to those skilled in the art who are familiar with this invention.
- the depth electrode within the secondary lumen be removable, thereby allowing continued fluid flow using the catheter after electrical sensing is no longer intended.
- the catheter assembly includes an outer flexible tube having a proximal end, a fluid-flow lumen extending therealong to the proximal end, and at least one radial aperture through the wall communicating with the fluid-flow lumen, the tube further defining a channel adjacent to the tube wall and extending therealong to the proximal end, and a depth electrode within the channel, extending along the length thereof and out the proximal end, the depth electrode having spaced electrical contacts exposed along the flexible tube.
- the depth electrode is a medical-grade polyurethane material with a Shore A hardness of at least about 50. It is highly preferable that the polyurethane material for the depth electrode have a Shore A hardness of about 55. It is also preferable that the outer flexible tube be an integral piece of medical-grade elastomeric tube with Shore A hardness of at least about 80, most preferably about 83.
- Another aspect of this invention is the method of using such catheter assembly.
- the method includes: providing a catheter assembly as described above; inserting the catheter assembly into the patient's brain, thereby facilitating concurrent electrical sensing and fluid flow; and withdrawing the depth electrode from the secondary lumen while the catheter assembly is within the patient's brain and thereby, allowing fluid flow to continue after electrical sensing is no longer intended.
- windows means the openings in the outer tube extending to the secondary lumen such that the electrical contacts are exposed to brain tissue.
- a catheter assembly in accordance with the present invention is generally designated by the reference numeral 10.
- Catheter assembly 10 allows intracranial treatment of a patient by providing an outer tube 12 and a principal lumen 14 as well as at least one radial aperture 16 through the wall communicating with the principal lumen 14 which cooperate to transfer fluids between a tissue region in the patient's brain and an external receptacle or device.
- Tube 12 further defines a secondary lumen 18 adjacent to the tube outer- wall surface 20 and extending therealong to a proximal end 22.
- Catheter assembly 10 includes a depth electrode 24 within secondary lumen 18 extending along the length thereof and out proximal end 22. Depth electrode 24 has spaced electrical contacts 26 exposed along tube 12 facilitating concurrent electrical sensing and fluid flow.
- catheter assembly 10 includes windows 30 on tube 12 which extend through outer tube 12 and are aligned with electrical contacts 26 of depth electrode 24.
- electrical contacts 26 along depth electrode 24 have diameters such that they extend at least partially into windows 30, thereby facilitating their electrical contact with brain tissue as seen in FIGURES 1-2 .
- electrical contacts 26 along depth electrode 24 are substantially flush with the outer- wall surface 36 of tube 12 as seen in FIGURE 7 .
- FIGURES 1-3 also illustrate that tube 12 includes a plurality of radial apertures 16 along and around tube 12.
- FIGURE 2 shows stylet 28 received within principal lumen 14 for insertion into the patient's brain.
- Stylet 28 provides rigidity to tube 12 if tube 12 is not rigid.
- Stylet 28 is generally removed after insertion of catheter assembly 10.
- Tube 12 includes principal lumen 14 which extends from proximal end 22 to aperture 16 as seen in FIGURES 1-2 .
- Principal lumen 14 has an inner diameter which may vary depending on the desired flow rate of fluid but is preferably between about 25 microns and 2.8 millimeters (drug delivery and drainage). It is very preferable that the inner diameter for principal lumen 14 is about 0.50 inches (1.3 millimeters). Depending on the size of principal lumen other insertion methods like a cannula may be used. Fluids may be transferred to or from a tissue region through principal lumen 14, e.g., drugs may be administered to tissue region, cerebral spinal fluid may be withdrawn, or both.
- FIGURE 3 illustrates that depth electrode 24 within secondary lumen 18 is removable, thereby allowing for increased fluid flow after electrical sensing/monitoring is no longer intended.
- FIGURE 3 also illustrates that depth electrode 24 includes electrical contacts 26 which can provide monitoring of brain tissue or which can also provide a location marker for determining the precise position of tube 12 within the brain.
- Preferred contacts 26 are platinum, platinum iridium or other biocompatible conductive material.
- Brain activity sensed by contacts 26 is transmitted to an external connector and then to a computer or instrument which records and/or analyzes such activity.
- Contacts 26 are preferably stainless steel or other alloys or materials which are non-corrosive conductors which can endure the sterilization process.
- depth electrode 24 includes two sets of electrical contacts 26, one set of electrical contacts 26 on proximal end 22 of depth electrode and one set of electrical contacts 26 on distal end 32 of depth electrode 24.
- Proximal end 22 and distal end 32 of depth electrode 24 correlate with proximal end 22 and distal end 32 of outer tube 12.
- Electrical contacts 26 are generally macro contacts of the collar-type which circumscribe outer surface of depth electrode 24. Contacts 26 on proximal end 22 of depth electrode 24 connect to contacts 26 on distal end 32 of depth electrode 24 to communicate (through wires 48) brain activity to a recording or analysis instrument. Contacts 26 on proximal end 22 do not enter the patient's brain, instead they provide connection to such an instrument.
- Tube 12 has a closed distal end 32.
- a luer fitting 34 as shown in FIGURE 1 , is inserted into principal lumen 14 at proximal end 22 during treatment.
- Luer fitting 34 can function as a connector for connecting catheter assembly 10 with a drainage system or the like.
- Cross-dimension of tube 12 is preferably between about 1.0 and 5.0 millimeters, most preferably about 2.5 millimeters and is comprised of polyurethane, silicone, polyimide, or other biocompatible material.
- polyurethane material is used for tube 12.
- Polyurethane material is also preferably used for depth electrode 24.
- the materials selected for tube 12 have a Shore A hardness of at least about 80 (on the Shore A scale of 0-100).
- a Shore A hardness of 83 is preferred for tube 12.
- tube 12 be an integral piece of medical-grade elastomeric tube.
- elastomer is a polymeric compound with elastic properties.
- depth electrode 24 is comprised of a polyurethane material having a Shore A hardness of at least about 50.
- a Shore A hardness of 55 is preferred for depth electrode 24.
- Hardness relates to compressibility of the material; the harder a material, the less compressible it is, and vice versa. Hardness also relates to resistance to deformation under pressure.
- FIGURES 4-6 illustrate that in cross-section, principal and secondary lumens 14, 18 are substantially circular, the size of secondary lumen 18 being smaller than the size of principal lumen 14. It is preferable that the inner diameter for secondary lumen 18 is about 0.034 inches.
- Tube outer-wall surface 36 is substantially smooth and has a major cylindrical portion 38 substantially parallel to the surface of principal lumen 14, a minor cylindrical portion 40 substantially parallel to the surface of secondary lumen 18, and transitional portions 42 therebetween on either side.
- transitional portions 42 (in cross-section) are other than concave. In other embodiments transitional portions 42 (in cross-section) are substantially linear.
- tube 12 does not exceed about 5.0 millimeters and be not smaller than about 1.0 millimeter.
- An alternate embodiment of catheter assembly 10 includes tube 12 having proximal end 22, a fluid-flow lumen 44 extending therealong to proximal end 22, and at least one radial aperture 16 through tube wall 36 communicating with lumen 44.
- Tube 12 further defines a channel 46 adjacent to tube wall 36 and extending therealong to proximal end 22.
- Depth electrode 24 can be removably withdrawn from channel 46, extending along the length thereof and out proximal end 22.
- Depth electrode 24 includes spaced electrical contacts 26 exposed along tube 12.
- a catheter assembly 10 including (a) an outer flexible tube 12 having a proximal end 22, a principal lumen 14 extending therealong to the proximal end 22, and at least one radial aperture 16 through the wall communicating with the lumen 14, tube 12 further defining a secondary lumen 18 adjacent to the tube outer-wall 20 surface and extending therealong to proximal end 22, and (b) a depth electrode 24 within secondary lumen 18, extending along the length thereof and out proximal end 22, depth electrode 24 having spaced electrical contacts 26 exposed along tube 12; (2) inserting the catheter assembly 10 into the patient's brain, thereby facilitating concurrent electrical sensing and fluid flow; and (3) withdrawing depth electrode 24 from secondary lumen 18 while catheter assembly 10 is within the patient's brain thereby, allowing fluid flow after electrical sensing is no longer intended.
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- Hospice & Palliative Care (AREA)
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- Social Psychology (AREA)
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- Electrotherapy Devices (AREA)
- External Artificial Organs (AREA)
Description
- The present invention relates to catheter assemblies for treatment of brain tissue and to devices for electrical stimulating/monitoring of brain activity.
- Depth electrodes have been utilized for a variety of brain-monitoring and brain-stimulating purposes related to epilepsy and a variety of movement disorders.
- For example, monitoring of electrical activity is important in ascertaining the focus of epileptogenic brain tissue and cells for the purpose of determining possibilities for later removal or treatment. Furthermore, highly-targeted electrical stimulation using depth electrodes has been used to suppress undesirable behavior resulting from various movement disorders.
- Small brain-insertable catheters have been used for a variety of fluid-removal and drug-delivery purposes. Fluid removal is often necessary or helpful in connection with brain injuries; likewise highly-targeted drug delivery to very specific portions of brain tissue is useful in a variety of medical situations.
- In a number of specific situations, insertion of both catheter devices and depth electrode devices is medically appropriate or helpful, but this of necessity has involved plural insertions into brain tissue. Fluid-movement and electrical functions are often needed or highly desirable at essentially the same locations within the brain tissue. It should be evident that insertions into brain tissue are risky procedures and that minimizing the number of insertions is desirable.
- A wide variety of probes have been created and are available. However, there is a need for improvement in brain-insertable probes, and it is to this need that this invention is directed.
-
US 2003/0014016 A1 discloses a method and device for introducing and navigating the device in a spinal subarchnoid space, the device being a catheter or sheath defining a first passageway. Intracranial access may be facilitated by introducing a second device through the first passageway, wherein the intracranial space can be navigated to place EEG electrodes in brain tissue.US 2003/0014016 A1 at least does not disclose a depth electrode within a secondary lumen and having spaced electrical contacts along the flexible tube. -
US 2004/0215162 A1 describes an intracranial catheter assembly comprising an outer catheter with a lumen and an inner catheter adapted to be received within said lumen. - In accordance with the present device, an intracranial catheter assembly is provided for precise treatment of brain tissue. The catheter assembly of this invention overcomes certain problems and shortcomings of the prior art and provides a unique structure satisfying plural intracranial monitoring and treatment needs.
- The catheter assembly of this invention includes (a) an outer flexible tube having a proximal end, a principal lumen extending therealong to the proximal end, and at least one radial aperture through the wall communicating with the lumen, wherein the at least one radial aperture and the principal lumen are configured to cooperate for transferring fluids between a tissue region in the patient's brain and an external receptacle or device, the tube further defining a secondary lumen next to and separate from the principal lumen and adjacent to the tube outer-wall surface and extending therealong to the proximal end, and (b) a depth electrode within the secondary lumen, extending along the length thereof and out the proximal end, the depth electrode having spaced electrical contacts exposed along the flexible tube, thereby facilitating concurrent electrical sensing and fluid flow wherein the outer tube includes windows therethrough which are aligned with the electrical contacts of the depth electrode and has a plurality of radial apertures axially-spaced along and around the outer tube. In certain preferred embodiments the outer tube has a closed distal end.
- In preferred embodiments, the assembly further includes a rigid stylet received within the principal lumen for purposes of insertion of the catheter assembly into the patient's brain. The rigid stylet is withdrawn from the assembly after insertion is complete.
- In some embodiments, a luer fitting is inserted into the principal lumen at the proximal end during treatment. In such embodiments, the luer fitting is a connector for connecting the catheter assembly with a drainage system or other device.
- In certain embodiments, the electrical contacts along the depth electrode have diameters such that they extend at least partially into the windows, thereby facilitating their electrical contact with brain tissue. In other embodiments, the electrical contacts along the depth electrode are substantially flush with the outer- wall surface.
- In some embodiments, in cross-section the principal and secondary lumens of the catheter assembly are substantially circular, the size of the secondary lumen is smaller than the size of the principal lumen, and the tube outer-wall surface is substantially smooth and has a major portion (cylindrical) substantially parallel to the surface of the principal lumen, a minor portion (cylindrical) substantially parallel to the surface of the secondary lumen, and transitional portions therebetween on either side. Such transitional portions are other than concave; it is preferable that in cross-section each transitional portions be substantially linear. It is also preferable that the largest cross-dimension of the outer flexible tube not exceed about 5.0 millimeters and be not smaller than about 1.0 millimeter. It should be noted, however, that many different cross-dimension sizes are acceptable for the catheter assembly and these will be apparent to those skilled in the art who are familiar with this invention.
- It is highly preferable that the depth electrode within the secondary lumen be removable, thereby allowing continued fluid flow using the catheter after electrical sensing is no longer intended.
- In other preferred embodiments, the catheter assembly includes an outer flexible tube having a proximal end, a fluid-flow lumen extending therealong to the proximal end, and at least one radial aperture through the wall communicating with the fluid-flow lumen, the tube further defining a channel adjacent to the tube wall and extending therealong to the proximal end, and a depth electrode within the channel, extending along the length thereof and out the proximal end, the depth electrode having spaced electrical contacts exposed along the flexible tube.
- Preferably, the depth electrode is a medical-grade polyurethane material with a Shore A hardness of at least about 50. It is highly preferable that the polyurethane material for the depth electrode have a Shore A hardness of about 55. It is also preferable that the outer flexible tube be an integral piece of medical-grade elastomeric tube with Shore A hardness of at least about 80, most preferably about 83.
- Another aspect of this invention is the method of using such catheter assembly. The method includes: providing a catheter assembly as described above; inserting the catheter assembly into the patient's brain, thereby facilitating concurrent electrical sensing and fluid flow; and withdrawing the depth electrode from the secondary lumen while the catheter assembly is within the patient's brain and thereby, allowing fluid flow to continue after electrical sensing is no longer intended.
- The term "windows" as used herein means the openings in the outer tube extending to the secondary lumen such that the electrical contacts are exposed to brain tissue.
- The drawings illustrate a preferred embodiment including the above-noted characteristics and features of the device. The device will be readily understood from the descriptions and drawings. In the drawings:
-
FIGURE 1 is a side elevation of a catheter assembly in accordance with this invention, with its insertion stylet removed, and dotted lines indicating the internal locations of the principal and secondary lumens. -
FIGURE 2 is a similar side elevation ofFIGURE 1 , but with the insertion stylet in place. -
FIGURE 3 is an enlarged, fragmentary, exploded view of the tip portion of the catheter assembly ofFIGURE 1 . -
FIGURE 4 is an enlarged cross-sectional view of the catheter assembly taken along section 4-4 as indicated inFIG. 2 . -
FIGURE 5 is an enlarged cross-sectional view of the catheter assembly taken along section 5-5 as indicated inFIG. 2 . -
FIGURE 6 is a further enlarged fragmentary view ofFIG. 5 as indicated by portion 6-6. -
FIGURE 7 is another cross-sectional view as inFIG. 4 but with the stylet having been removed. -
FIGURE 8 is a side elevation of another catheter assembly similar to that ofFIGURE 1 except that the electrical contacts of the depth electrode have outer surfaces which are substantially flush with the outer surface of the outer-tube wall. - Referring to
FIGURES 1-8 , a catheter assembly in accordance with the present invention is generally designated by thereference numeral 10.Catheter assembly 10 allows intracranial treatment of a patient by providing anouter tube 12 and a principal lumen 14 as well as at least oneradial aperture 16 through the wall communicating with the principal lumen 14 which cooperate to transfer fluids between a tissue region in the patient's brain and an external receptacle or device. Tube 12 further defines a secondary lumen 18 adjacent to the tube outer-wall surface 20 and extending therealong to aproximal end 22.Catheter assembly 10 includes adepth electrode 24 within secondary lumen 18 extending along the length thereof and outproximal end 22.Depth electrode 24 has spacedelectrical contacts 26 exposed alongtube 12 facilitating concurrent electrical sensing and fluid flow. - As seen in
FIGURES 1-3 ,catheter assembly 10 includeswindows 30 ontube 12 which extend throughouter tube 12 and are aligned withelectrical contacts 26 ofdepth electrode 24. In some embodiments,electrical contacts 26 alongdepth electrode 24 have diameters such that they extend at least partially intowindows 30, thereby facilitating their electrical contact with brain tissue as seen inFIGURES 1-2 . In another embodiment,electrical contacts 26 alongdepth electrode 24 are substantially flush with the outer-wall surface 36 oftube 12 as seen inFIGURE 7 .FIGURES 1-3 also illustrate thattube 12 includes a plurality ofradial apertures 16 along and aroundtube 12. -
FIGURE 2 shows stylet 28 received within principal lumen 14 for insertion into the patient's brain.Stylet 28 provides rigidity totube 12 iftube 12 is not rigid.Stylet 28 is generally removed after insertion ofcatheter assembly 10. -
Tube 12 includes principal lumen 14 which extends fromproximal end 22 toaperture 16 as seen inFIGURES 1-2 . Principal lumen 14 has an inner diameter which may vary depending on the desired flow rate of fluid but is preferably between about 25 microns and 2.8 millimeters (drug delivery and drainage). It is very preferable that the inner diameter for principal lumen 14 is about 0.50 inches (1.3 millimeters). Depending on the size of principal lumen other insertion methods like a cannula may be used. Fluids may be transferred to or from a tissue region through principal lumen 14, e.g., drugs may be administered to tissue region, cerebral spinal fluid may be withdrawn, or both.FIGURE 3 illustrates thatdepth electrode 24 within secondary lumen 18 is removable, thereby allowing for increased fluid flow after electrical sensing/monitoring is no longer intended. -
FIGURE 3 also illustrates thatdepth electrode 24 includeselectrical contacts 26 which can provide monitoring of brain tissue or which can also provide a location marker for determining the precise position oftube 12 within the brain.Preferred contacts 26 are platinum, platinum iridium or other biocompatible conductive material. Brain activity sensed bycontacts 26 is transmitted to an external connector and then to a computer or instrument which records and/or analyzes such activity.Contacts 26 are preferably stainless steel or other alloys or materials which are non-corrosive conductors which can endure the sterilization process. - As seen in
FIGURES 1-2 ,depth electrode 24 includes two sets ofelectrical contacts 26, one set ofelectrical contacts 26 onproximal end 22 of depth electrode and one set ofelectrical contacts 26 ondistal end 32 ofdepth electrode 24. (Proximal end 22 anddistal end 32 ofdepth electrode 24 correlate withproximal end 22 anddistal end 32 ofouter tube 12.)Electrical contacts 26 are generally macro contacts of the collar-type which circumscribe outer surface ofdepth electrode 24.Contacts 26 onproximal end 22 ofdepth electrode 24 connect tocontacts 26 ondistal end 32 ofdepth electrode 24 to communicate (through wires 48) brain activity to a recording or analysis instrument.Contacts 26 onproximal end 22 do not enter the patient's brain, instead they provide connection to such an instrument. -
Tube 12 has a closeddistal end 32. A luer fitting 34, as shown inFIGURE 1 , is inserted into principal lumen 14 atproximal end 22 during treatment. Luer fitting 34 can function as a connector for connectingcatheter assembly 10 with a drainage system or the like. - Cross-dimension of
tube 12 is preferably between about 1.0 and 5.0 millimeters, most preferably about 2.5 millimeters and is comprised of polyurethane, silicone, polyimide, or other biocompatible material. Preferably, polyurethane material is used fortube 12. Polyurethane material is also preferably used fordepth electrode 24. - It is desirable that the materials selected for
tube 12 have a Shore A hardness of at least about 80 (on the Shore A scale of 0-100). A Shore A hardness of 83 is preferred fortube 12. It is also desirable thattube 12 be an integral piece of medical-grade elastomeric tube. (An "elastomer" is a polymeric compound with elastic properties.) It is desirably thatdepth electrode 24 is comprised of a polyurethane material having a Shore A hardness of at least about 50. A Shore A hardness of 55 is preferred fordepth electrode 24. Persons of ordinary skill in the art will be aware of numerous other materials satisfying the requirements fortube 12 anddepth electrode 24. - One skilled in the art will recognize that certain materials having resilient compressibility will have lower density than materials having lesser resilient compressibility. More often materials having greater resilient compressibility have a lower measure of hardness on the Shore A scale than less compressible materials. "Hardness" relates to compressibility of the material; the harder a material, the less compressible it is, and vice versa. Hardness also relates to resistance to deformation under pressure.
-
FIGURES 4-6 illustrate that in cross-section, principal and secondary lumens 14, 18 are substantially circular, the size of secondary lumen 18 being smaller than the size of principal lumen 14. It is preferable that the inner diameter for secondary lumen 18 is about 0.034 inches. Tube outer-wall surface 36 is substantially smooth and has a majorcylindrical portion 38 substantially parallel to the surface of principal lumen 14, a minorcylindrical portion 40 substantially parallel to the surface of secondary lumen 18, andtransitional portions 42 therebetween on either side. In some embodiments transitional portions 42 (in cross-section) are other than concave. In other embodiments transitional portions 42 (in cross-section) are substantially linear. - While many dimensions are acceptable, it is preferably that the largest cross-dimension of
tube 12 does not exceed about 5.0 millimeters and be not smaller than about 1.0 millimeter. - An alternate embodiment of
catheter assembly 10 includestube 12 havingproximal end 22, a fluid-flow lumen 44 extending therealong toproximal end 22, and at least oneradial aperture 16 throughtube wall 36 communicating with lumen 44.Tube 12 further defines a channel 46 adjacent totube wall 36 and extending therealong toproximal end 22.Depth electrode 24 can be removably withdrawn from channel 46, extending along the length thereof and outproximal end 22.Depth electrode 24 includes spacedelectrical contacts 26 exposed alongtube 12. - In a highly preferred method, a
catheter assembly 10 is provided including (a) an outerflexible tube 12 having aproximal end 22, a principal lumen 14 extending therealong to theproximal end 22, and at least oneradial aperture 16 through the wall communicating with the lumen 14,tube 12 further defining a secondary lumen 18 adjacent to the tube outer-wall 20 surface and extending therealong toproximal end 22, and (b) adepth electrode 24 within secondary lumen 18, extending along the length thereof and outproximal end 22,depth electrode 24 having spacedelectrical contacts 26 exposed alongtube 12; (2) inserting thecatheter assembly 10 into the patient's brain, thereby facilitating concurrent electrical sensing and fluid flow; and (3) withdrawingdepth electrode 24 from secondary lumen 18 whilecatheter assembly 10 is within the patient's brain thereby, allowing fluid flow after electrical sensing is no longer intended. - A wide variety of materials are available for the various parts discussed and illustrated herein. While the principles of this invention have been described in connection with specific embodiments, it should be understood clearly that these descriptions are made only by way of example and are not intended to limit the scope of the invention.
Claims (12)
- A catheter assembly (10) for intracranial treatment of a patient comprising:• an outer flexible tube (12) having a proximal end (22), a principal lumen (14) extending therealong to the proximal end (22), and at least one radial aperture (16) through the wall communicating with the lumen (14), wherein the at least one radial aperture (16) and the lumen (14) are configured to cooperate for transferring fluids between a tissue region in the patient's brain and an external receptacle or device, the tube (12) further defining a secondary lumen (18) next to and separate from the principal lumen (14) and adjacent to the tube outer-wall surface (20, 36) and extending therealong to the proximal end (22); and• a depth electrode (24) within the secondary lumen (18), extending along the length thereof and out the proximal end (22), the depth electrode (24) having spaced electrical contacts (26) exposed along the flexible tube (12),thereby facilitating concurrent electrical sensing and fluid flow,
wherein the outer tube (12) includes windows (30) therethrough aligned with the electrical contacts (26) of the depth electrode (24) and has a plurality of radial apertures (16) along and around the outer tube. - The catheter assembly (10) of claim 1 wherein the outer tube has a closed distal end (32).
- The catheter assembly (10) of claim 1 further comprising a rigid stylet (28) received within the principal lumen (14) during and for purposes of insertion into the patient's brain, the stylet (28) being removable after insertion of the catheter assembly (10).
- The catheter assembly (10) of claim 1 further including a luer fitting (34) inserted into the principal lumen (14) at the proximal end (22) during treatment, the luer fitting (34) being a connector for connecting the catheter assembly (10) with a drainage system.
- The catheter assembly (10) of claim 1 wherein the electrical contacts (26) along the depth electrode (24) have diameters such that they extend at least partially into the windows (30), thereby facilitating their electrical contact with brain tissue.
- The catheter assembly (10) of claim 5 wherein the electrical contacts (26) along the depth electrode (24) are substantially flush with the outer-wall surface (36).
- The catheter assembly (10) of claim 1 wherein in cross-section:• the principal (14) and secondary (18) lumens are substantially circular, the size of the secondary lumen (18) being smaller than the size of the principal lumen (14); and• the tube outer- wall surface (20, 36) is substantially smooth and has a major cylindrical portion (38) substantially parallel to the surface of the principal lumen (14), a minor cylindrical portion (40) substantially parallel to the surface of the secondary lumen (18), and transitional portions (42) therebetween on either side, each transitional portion (42) being other than concave.
- The catheter assembly (10) of claim 7 wherein in cross-section each transitional portion (42) is substantially linear and the largest cross-dimension of the outer flexible tube (12) does not exceed 5.0 millimeters and the smallest cross-dimension is not smaller than 1.0 millimeter.
- The catheter assembly (10) of claim 1 wherein the depth electrode (24) within the secondary lumen (18) is removable, thereby allowing fluid flow after electrical sensing is no longer intended.
- The catheter assembly (10) of claim 1 wherein the depth electrode (24) includes a tube of a polyurethane material having a Shore A hardness of at least about 50.
- The catheter assembly (10) of claim 1 wherein the outer flexible tube (12) is an integral piece of medical-grade elastomeric tube having a Shore A hardness of at least about 80.
- The catheter assembly (10) of claim 11 wherein the depth electrode (24) includes a tube of a polyurethane material having a Shore A hardness of at least about 50.
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Application Number | Priority Date | Filing Date | Title |
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US13/687,254 US9072864B2 (en) | 2012-11-28 | 2012-11-28 | Catheter with depth electrode for dual-purpose use |
PCT/US2013/065399 WO2014084977A1 (en) | 2012-11-28 | 2013-10-17 | Catheter with depth electrode for dual-purpose use |
Publications (3)
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EP2925221A1 EP2925221A1 (en) | 2015-10-07 |
EP2925221A4 EP2925221A4 (en) | 2016-07-06 |
EP2925221B1 true EP2925221B1 (en) | 2021-06-09 |
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US (1) | US9072864B2 (en) |
EP (1) | EP2925221B1 (en) |
JP (1) | JP6249496B2 (en) |
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- 2013-10-17 ES ES13858315T patent/ES2886463T3/en active Active
- 2013-10-17 KR KR1020177021928A patent/KR101826181B1/en active IP Right Grant
- 2013-10-17 JP JP2015545046A patent/JP6249496B2/en active Active
- 2013-10-17 KR KR1020157011737A patent/KR20150091305A/en active Application Filing
- 2013-10-17 AU AU2013353416A patent/AU2013353416B2/en active Active
- 2013-10-17 CN CN201380059688.4A patent/CN104780836B/en active Active
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AU2013353416B2 (en) | 2017-05-11 |
AU2017213481A1 (en) | 2017-08-31 |
EP2925221A4 (en) | 2016-07-06 |
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US20140148780A1 (en) | 2014-05-29 |
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JP6249496B2 (en) | 2017-12-20 |
AU2013353416A1 (en) | 2015-04-16 |
ES2886463T3 (en) | 2021-12-20 |
AU2017213481B2 (en) | 2018-11-08 |
KR20170094006A (en) | 2017-08-16 |
KR20150091305A (en) | 2015-08-10 |
CN104780836A (en) | 2015-07-15 |
KR101826181B1 (en) | 2018-02-06 |
JP2015535482A (en) | 2015-12-14 |
US9072864B2 (en) | 2015-07-07 |
EP2925221A1 (en) | 2015-10-07 |
CA2892187A1 (en) | 2014-06-05 |
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